Navigating GMO Landscape following the EU Clinical Trial Regulation 536/2014 implementation
WEBINAR WILL BE RECORDED
Join Ergomed regulatory webinar on EU GMO considerations in light of the centralized CTA submission under the EU Clinical Trial Regulation 536/2014. Our expert speakers will guide you through the EU GMO framework, the environmental risk assessments, and the EMA action plan attempting to create an approach to clarify and harmonise national GMO requirements. Don't miss this opportunity to gain profound insights into the forefront of regulatory evolution.
What is a GMO and a GMM?
Introduction to EU GMO legal framework
GTMP GMO environmental risk assessments
GMO considerations and CTR (EU) No 536/2014
Q & A
Anyone with the event link can attend
Please register for this Webinar to view the dial-in info.
Marcelina has 15 years of experience in global regulatory affairs, supporting Sponsor companies in the execution of successful regulatory strategies for their clinical research programs. She provides Ergomed clients with regulatory solutions and...
Lara joined Ergomed in 2023 and within the Regulatory Affairs department is the Biologics and ATMP CMC and nonclinical subject matter expert. She possesses a PhD in Biotechnology with over 20 years of CMC and clinical development experience in...
Founded in 1997, Ergomed is a global provider of high-quality services to the biopharmaceutical industry, spanning all phases of clinical trials, post-approval pharmacovigilance, and medical information. Ergomed Clinical Research is a complete,...